Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01559831
First received: March 19, 2012
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.


Condition Intervention Phase
Japanese Encephalitis
Biological: IXIARO
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Immune Responses to Revaccination After Potentially Insufficient Priming With the Japanese Encephalitis Vaccine IXIARO Batch JEV09L37

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Seroconversion rate (SCR) at Day 28 [ Time Frame: at Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SCR at Day 0 [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Geometric Mean Titer at Day 0 and 28 [ Time Frame: Day 0 and Day 28 ] [ Designated as safety issue: No ]
  • Rate of Adverse Events up to Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IXIARO
IXIARO, applied according to licensed dose, intramuscular
Biological: IXIARO
Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular

Detailed Description:

IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

A total of up to 50 subjects having received primary immunization of IXIARO batch JEV09L37 and who have not yet been revaccinated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects 18 years or older having received IXIARO batch JEV09L37 during primary immunization
  • In female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
  • Written informed consent obtained from the subject prior to any study-related procedures

Exclusion Criteria:

  • Vaccination against Yellow fever, Dengue Fever, West Nile Fever or TBE or vaccination with any JE vaccine since primary immunization with IXIARO JEC09L37
  • Clinical manifestation of any flavivirus infection since primary immunization with IXIARO JEC09L37
  • Acute febrile infections or exacerbation of chronic infection on the day of IXIARO vaccination
  • Pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects.
  • Use of any other investigational or non-registered drug within 30 days prior to the first vaccination with IXIARO Visit 1 and during the study period
  • Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
  • Persons who are committed to an institution
  • At Day 0, upcoming scheduled travel to a JE endemic region
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559831

Locations
United Kingdom
UCLH Foundation Trust
London, United Kingdom, WC1E 6JB
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Chair: Vera Kadlecek, Mag. Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01559831     History of Changes
Other Study ID Numbers: IC51-319
Study First Received: March 19, 2012
Last Updated: March 7, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Valneva Austria GmbH:
Japanese Encephalitis
IXIARO
Japanese Encephalitis Vaccine

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalitis
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 16, 2014